ZALEPLON- zaleplon capsule 
Northstar Rx LLC

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MEDICATION GUIDE
ZALEPLON CAPSULES, USP C-IV

Read this Medication Guide before you start taking zaleplon capsules and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. You and your doctor should talk about zaleplon capsules when you start taking them and at regular checkups.

What is the most important information I should know about zaleplon capsules?

After taking zaleplon capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with zaleplon capsules. Reported activities include:

Important:

1. Take zaleplon capsules exactly as prescribed

2. Do not take zaleplon capsules if you:

3. Call your doctor right away if you find out that you have done any of the above activities after taking zaleplon capsules.

What are zaleplon capsules?

Zaleplon capsules are a sedative-hypnotic (sleep) medicine. Zaleplon capsules are used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon capsules do not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.

Zaleplon capsules are not for children.

Zaleplon capsules are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zaleplon capsules in a safe place to prevent misuse and abuse. Selling or giving away zaleplon capsules may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take zaleplon capsules?

Do not take zaleplon capsules if you are allergic to anything in them. See the end of this Medication Guide for a complete list of ingredients in zaleplon capsules.

Zaleplon capsules may not be right for you. Before starting zaleplon capsules, tell your doctor about all of your health conditions, including if you:

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact, sometimes causing side effects. Do not take zaleplon capsules with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take zaleplon capsules?

What are the possible side effects of zaleplon capsules?

Serious side effects of zaleplon capsules include:

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zaleplon capsules.

Common side effects of zaleplon capsules include:

These are not all the side effects of zaleplon capsules. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800- FDA- 1088.

How should I store zaleplon capsules?

General Information about zaleplon capsules

This Medication Guide summarizes the most important information about zaleplon capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zaleplon capsules that was written for healthcare professionals.

What are the ingredients in zaleplon capsules?

Active Ingredient: zaleplon, USP

Inactive Ingredients: lactose monohydrate, pregelatinized starch, microcrystalline cellulose, silicon dioxide, magnesium stearate, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40, and FD&C yellow #5. Ink constituents are: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.

Zaleplon capsules 5 mg – Dark green colored cap and light blue colored body, “size 4” hard gelatin capsules imprinted with "ZLP" on body and “2122” on cap with black ink, filled with white to off white granular powder.

Zaleplon capsules 10 mg - Dark green colored cap and Opaque blue body, “size 4” hard gelatin capsules imprinted with "ZLP" on body and “2130” on cap with black ink, filled with white to off white granular powder.

Rx only

Manufactured for: Northstar Rx LLC

Memphis, TN 38141

Toll free number: 1 800 206 7821

Manufactured by: Orchid Healthcare

(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)

Irungattukottai - 602 105, India

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: May 2013

948026316

Revised: 05/2013
 
Northstar Rx LLC